NCT01496924

Brief Summary

There is an association between increased risk of oropharyngeal dysphagia and artificial ventilation through endotracheal tube, followed by tracheostomy. The aim of the present study is to analyze the outcomes of an early swallowing rehabilitation program of dysphagic tracheostomized patients under mechanical ventilation at the intensive care unit.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 21, 2011

Status Verified

December 1, 2011

Enrollment Period

4 years

First QC Date

November 21, 2011

Last Update Submit

December 19, 2011

Conditions

Dysphagia

Keywords

DysphagiaIntensive care unitsDeglutition disordersRehabilitation

Outcome Measures

Primary Outcomes (1)

  • dysphagia improvement

    Otorhinolaryngological assessment will be carried out before and after treatment by means of a bedside video nasal endoscopic examination of swallowing, and included the evaluation of the following aspects: mobility of vocal folds, saliva and food swallowing, swallowing trigger time, food stasis in pharyngeal recesses, laryngeal penetration, tracheal aspiration, pharyngeal clearance after swallowing, laryngeal sensitivity and cough reflex, both by the speech-language pathologist and the otorrhinolaryngologist

    participants will be followed for the duration of ICU stay, an expected average of 2 weeks"

Study Arms (1)

speech therapy group

OTHER

All dysphagic patients will be submitted to speech therapy

Other: speech therapy

Interventions

speech therapyOTHER

A single oral-motor technique will be used in a 10-times series intercalated with rest. Swallowing training techniques comprised indirect therapy (swallowing of saliva) and direct therapy (swallowing of food).

speech therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • admission in an ICU
  • mechanical ventilation and tracheostomy for at least 48 hours
  • appropriate level of consciousness (Glasgow coma scale ≥ 11)
  • hemodynamic stability without need for vasoactive drugs
  • minimum mechanical ventilation parameters characterized by pressure support ventilation (PSV) ≤ 20 cm H2O, positive end-expiratory pressure (PEEP) ≤ 8 cm H2O, fraction of inspired oxygen (FiO2) ≤ 50 and respiratory rate ≤ 30 inspirations per minute.

You may not qualify if:

  • surgery with resection of structures of oral cavity, pharynx, larynx and/or esophagus
  • nasal fracture or skull base fracture preventing otorhinolaryngological exam
  • possible surgical treatment after ICU admission with no reasonable time for carrying out the planned intervention
  • degenerative diseases characterized by outbreaks and remissions
  • past history of oropharyngeal dysphagia
  • previous speech therapy
  • excessive amount of thick tracheal secretion requiring frequent tracheal suctioning
  • end-stage of chronic obstructive pulmonary disease
  • tracheoesophageal fistula
  • allergy to dyes
  • low survival expectancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit - Hospital Sao Paulo

São Paulo, São Paulo, 04024900, Brazil

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Katia Alonso, PHD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katia Alonso, PHD

CONTACT

55 11 92119858katiaalonso@terra.com.br

Maria Inez Goncalves, PHD

CONTACT

55 11 55497500

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 21, 2011

First Posted

December 21, 2011

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

December 21, 2011

Record last verified: 2011-12

Locations

BR(1)